Basilea Pharmaceutica Ltd. (SIX: BSLN)
provided an update today on the phase 3 program with the novel antifungal
isavuconazole that is being developed in collaboration with Astellas Pharma
Inc.
Topline data from the SECURE and VITAL phase 3 studies are on track to be
available in the second half of 2013. The SECURE registration study
evaluates
the safety and efficacy of once-daily isavuconazole versus twice-daily
voriconazole for the primary treatment of life-threatening invasive fungal
disease caused by Aspergillus species. The VITAL study is an open-label
phase 3
study in the treatment of aspergillosis patients with pre-existing renal
impairment or with invasive fungal disease caused by emerging and often
fatal
fungi. With 150 patients enrolled, the VITAL study has now completed
recruitment, which was extended beyond its initial target to further expand
the
database on the use of isavuconazole in the primary treatment of emerging
fungal
infections for which currently only limited treatment options exist. The
data
from the SECURE and VITAL studies could form the basis of an initial filing
in
the first part of 2014.

The ACTIVE phase 3 study is evaluating the safety and efficacy of
intravenously
(i.v.) and orally administered isavuconazole versus i.v. caspofungin
followed by
oral voriconazole in the treatment of invasive Candida infections. The
study's
primary efficacy endpoint of overall response will be moved to the end of
intravenous treatment and assessed by a Data Review Committee. The previous
assessment at two weeks after i.v. and oral treatment will remain a
secondary
efficacy endpoint. There are no changes in the overall operational study
conduct. The protocol change will facilitate the comparison to data
obtained
from previous registration trials in invasive Candida infections. The study
is
expected to continue to recruit in 2014.

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "We are
on
track to provide the first data from the SECURE and VITAL phase 3 studies
in the
second half of this year. The move of the ACTIVE study outcome assessment
time
point will facilitate the comparison of the efficacy of isavuconazole to
the
data from previous registration trials investigating echinocandins. It
reflects
the most recent thinking of health authorities on the design and analysis
of
phase 3 clinical trials investigating antifungals for the treatment of
invasive
yeast infections."

In addition, the European Medicines Agency has agreed to the Pediatric
Investigation Plans (PIP) of isavuconazole for the treatment of invasive
aspergillosis, mucormycosis and Candida infections in children.

About isavuconazole

Isavuconazole is an investigational intravenous and oral broad-spectrum
antifungal. In collaboration with Astellas Pharma Inc., isavuconazole is
being
investigated in phase 3 clinical studies for the treatment of severe
invasive
fungal infections. The drug demonstrated in-vitro and in-vivo coverage of a
broad range of yeasts (such as Candida species) and molds (such as
Aspergillus
species) as well as in-vitro activity against emerging and often fatal
molds
including those that cause mucormycosis. In clinical studies to date,
isavuconazole achieved predictable drug levels supporting reliable dosing
and a
switch from once-daily intravenous to oral administration. The intravenous
formulation of isavuconazole, which is water-soluble, does not contain
possibly
kidney damaging solubilizers and has the potential to be given to patients
with
pre-existing renal impairment. In the U.S. isavuconazole has fast-track
status
and was granted orphan drug designation for the treatment of invasive
aspergillosis.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the Company focuses on innovative pharmaceutical
products in
the therapeutic areas of bacterial infections, fungal infections and
oncology,
targeting the medical challenge of rising resistance and non-response to
current
treatment options.

Disclaimer

This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition,
performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different
from
any future results, performance or achievements expressed or implied by
such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new information,
future
events or otherwise.